Catheter assembly

ABSTRACT

A catheter assembly with a catheter and a package for a catheter are provided. The package and catheter is provided with a seal that restricts passage of fluid between the package and the catheter. The assembly allows the catheter to be used without complete removal from the package. During urination, the assembly prevents the flow of urine from the outlet of the catheter and back through the package in a direction towards the user of the catheter. The seal allows the catheter to be dispensed from the package while the sealing is maintained and the assembly thus allows non-contaminated insertion and use of the catheter while the catheter is partly maintained in the package.

This is a nationalization of PCT/DK02/00447 filed Jun. 28, 2002 andpublished in English.

FIELD OF THE INVENTION

The present invention relates to a urinary catheter assembly comprisinga package allowing for storage of the catheter and for contaminationfree insertion of the catheter into a natural or an artificial urinarycanal of an individual.

BACKGROUND OF THE INVENTION

Catheters for draining the bladder are increasingly used forintermittent as well as indwelling or permanent catheterisation.Typically, catheters are used by patients suffering from urinaryincontinence or by disabled individuals like para- or tetraplegics whomay have no control permitting voluntary urination and for whomcatheterisation may be the way of urinating.

Typically, catheters are provided to the user enveloped in a completelysealed and sterilised package. During use and prior to insertion, thecatheter is typically removed completely from the package whereby apotential contamination of the catheter may occur, e.g. if the userunintentionally touches the catheter or if the catheter touchessurrounding obstacles, e.g. a toilet seat, a wash basin etc. Catheterpackages and assemblies of catheters and packages exist, wherein both aproximal end and a distal end of the package may be opened, thusallowing for draining the urine through a catheter which is still atleast partly enveloped in the package. Thereby, the user may urinatewithout completely exposing the catheter and the risk of contaminationis reduced. However, since there is a clearance between the innersurface of the catheter package and the outer surface of the catheteritself, urine may flow backwards in the package in a direction oppositeto the flow direction inside the catheter. An unwanted situation is thaturine or other liquid substances, e.g. a lubricant or water applied tothe catheter for the purpose of reducing the surface friction,contaminates the user of the catheter and/or the surroundings.

Since only the inserted part of the catheter is exposed from the packageprior to insertion of the catheter, another unwanted situation may bethat the user unintentionally forgets to open the other end of thecatheter package. An amount of urine may thereby build up in thecatheter package and possibly cause a back-flow in the catheter tube. Inthis case, there is a risk of severe contamination of the surroundingsand also a possibility of back-flow into the bladder.

Moreover, existing catheters are provided in various sizes. As anexample, catheters, which are relatively long are offered for maleindividuals whereas relatively short catheters are offered for femaleindividuals. Evidently, more variants of the same product imply problemsand costs for the providers of urinary catheters.

Catheter assemblies comprising a catheter and a package which includesan amount of a liquid substance, e.g. a lubricant for a conventionalcatheter or a liquid swelling medium for a hydrophilic catheter exist.Some of the existing packages provide a combination between a storagevolume for sterile storage of the catheter and a reservoir forcollection of liquid substances, e.g. for collection of frictionreducing substances or for collection of urine. Typically, there is alarge disproportion of the storage capacity necessary for storing thefriction-reducing substance and the urine, respectively. Accordingly,the known catheter assemblies of this kind are provided with arelatively small storage container for storing the friction-reducingsubstance inside the relatively large urine reservoir. It is adisadvantage of the known assemblies that the user, prior to insertionof the catheter into the urinary canal, will have to rupture the storagecontainer in order to achieve a reduced surface friction of thecatheter. Especially, it is a disadvantage in the event that thecatheter is a hydrophilic-coated catheter. In this case, the user wouldneed to open the storage container to allow a liquid swelling mediumstored therein to activate the coating and subsequently wait for atleast 30 seconds in order to complete the activation of the coatingprior to the insertion of the catheter.

DESCRIPTION OF THE INVENTION

It is an object of the present invention to overcome the above describeddisadvantages of the known catheter assemblies by providing a urinarycatheter assembly which, according to a first aspect of the invention,allows the insertion of a catheter into a urinary canal directly fromthe package without touching the catheter and without contamination ofthe surroundings. The assembly comprises:

-   -   a urinary catheter defining a conduit and having a proximal end        adapted for insertion into a urinary canal of an individual and        an opposite distal end, and    -   a catheter package having a hose with a cavity for accommodation        of the catheter and, in a proximal end thereof, a catheter        outlet adapted to dismantle the proximal end of the catheter        from the catheter package, and    -   sealing means adapted to provide a substantially liquid tight        seal between the catheter package and the urinary catheter,        while the catheter is being dismantled from the package.

Due to the sealing means, the catheter may be dismantled from thepackage until a catheter length sufficient for the opening of thebladder is exposed. At this stage, urine may be drained into theproximal end of the catheter and from the catheter into the hose andthrough the hose to a place of disposal, e.g. to the lavatory. The hoseof the package thus functions as an extension of the catheter allowingthe user e.g. to reach the lavatory without having to stand up from awheelchair or a bed etc. Since the sealing means seals between thecatheter and the hose, it is ensured that urine does not flow backbetween the hose and the catheter so as to drain out at the end of thepackage from which the catheter is being dismantled, i.e. the end of thepackage which extends in a direction towards the individual. As isevident, draining of fluids through this end may cause contamination ofthe surroundings and/or the individual.

The sealing means may be provided in the proximal end of the package,e.g. constituting a closure for the proximal end of the package. As anexample, the closure may have a rupturable portion with a shape whichmatches the outer cross-sectional shape of the catheter. When thecatheter is removed through the rupturable portion, the closure willsealingly surround the catheter while the catheter is being dismantled.The cavity is thereby defining a receptacle between the catheter and thehose. The receptacle may e.g. be used for storage of a friction-reducingsubstance.

The sealing means may also be arranged between an outer surface of theurinary catheter and an inner surface of the hose. As an example, thesealing means may be provided in the form of a sliding seal adapted tomove longitudinally in relation to one of either the inner surface ofthe hose, the outer surface of the catheter or both, while stillproviding a substantial liquid tight passage therein between. The cavitythereby defines an upper receptacle located near the proximal end of thepackage and an oppositely located lower receptacle between the catheterand the hose. The upper receptacle may advantageously be used forstoring a friction reducing substance for treatment of at least theproximal end of the catheter in the package.

The catheter or at least a section thereof may be provided with ahydrophilic surface, either in the form of a coated catheter or in theform of a catheter made throughout of a hydrophilic material. Whentreated with a liquid swelling medium, such a surface will provide anexcellent lubrication for the insertion and also provide compatibilitywith the body tissue.

The catheter may also be of the traditional type wherein the lowfriction character is obtained by application of a lubricant differentfrom water, e.g. a silicone based lubricant, the lubricant being appliedto at least a section of the catheter.

The liquid swelling medium for a hydrophilic surface may be provided inthe package, especially in the upper storage compartment, near theproximal end of the catheter, when the catheter is arranged in thepackage. Thereby, the low friction character will be initiated alreadywhen the catheter is being arranged in the package. The liquid swellingmedium may simply be a saline solution, a bactericidal solution capableof swelling the hydrophilic surface and capable of keeping the surfacein a sterile condition or it may be any suitable liquid swelling medium.The swelling may also be initiated already before packaging of thecatheter, the catheter then being packed in a substantially gasimpermeable package for conservation of the moistened surface.Furthermore, the liquid swelling medium may be provided in a capsule orcontainer directly within the hose member together with the catheter forswelling of the hydrophilic material immediately prior to the insertion.

It is an advantage to provide the catheter package in a material whichis at least substantially gas and water impermeable, which is durable toat least moderate external conditions such as temperature variations andlight. The material should at least substantially maintain itsproperties over a period of up to 12 or more months, e.g. up to 24month. The catheter package and/or the hose member could thereforepreferably be made from silicone or a thermoplastic elatomeric material,other thermoplastic materials, curable elastomeric materials, polyamideresins or elastomers or any mixture thereof, i.e. the group may comprisematerials like, PA, PP, PVC, PU, PE, latex, and/or Kraton™. All parts ofthe catheter package may be made from two foils of a sheet materialjoined along edges, e.g. by melting or gluing or in any other way beadhesively bonding the foils together. The package may also be made froman extruded substantially tubular member being closed in both ends. Thefoil may advantageously be made from laminates of different materials.One layer may e.g. be made from aluminium or similar metal or from acomposition of metals, e.g. comprising aluminium. Such a layer willprovide a completely gas-impermeable package.

The proximal end and the distal end of the catheter package could beprovided with an even structure. However, it will be preferred that theproximal end of the package is provided with opening means adapted toremove the proximal end of the catheter. Similarly, the distal end ofthe package may be provided with opening means adapted specifically fordraining fluid substances from the package. The fluid substances mayeither be a friction-reducing medium or urine.

Preferably, the hose member is an elongate and/or tubular member adaptedto accommodate at least a major part of the catheter. If the catheter isof the kind which develops a low friction surface character upontreatment with a liquid medium or substance, it may be an advantage toprovide the liquid medium in the package and preferably in the hosemember. The catheter will thereby be treated already upon removal of thecatheter from the package. For this purpose, the hose member maypreferably be adapted to relatively closely enclose the catheter. As anexample, the inner diameter or the cross-sectional area within the innersurface of the hose member may be in the range of 1.1-2 times the outerdiameter or the cross-sectional area within the outer surface of thecatheter, such as 1.2-1.9 times, such as 1.3-1.8, such as 1.4-1.7, suchas 1.5-1.6, such as in the size of 1.55 times the outer diameter or thecross-sectional area of the catheter. Alternatively, the liquid mediummay be contained in a pouch connected to the package. The pouch may e.g.constitute a closure for dosing either the proximal or the distal end ofthe package. Preferably, the pouch is integrated in a closure for dosingthe proximal end of the package, which end is located near the proximalend of the catheter.

If the catheter is a hydrophilic catheter, i.e. if the catheter iseither coated with a hydrophilic coating or made completely from ahydrophilic material, the liquid substance may be water or awater/saline solution. If the catheter is of the traditional type havinga primarily hydrophobic surface, the liquid substance may be alubricant, e.g. based on silicone.

The sealing means could be provided in the form of an obstruction whichsubstantially prevents a liquid substance to pass between the innersurface of the package and outer surface of the catheter. The sealingmeans thus divides the space confined between the catheter and the hosemember into an upper receptacle in the direction towards the proximalend of the catheter and package and a lower receptacle in the directiontowards the distal end of the catheter and package.

As an example, the sealing means could be provided as a radiallyoutwardly extending protrusion of the outer surface of the catheter oras an inwardly extending protrusion of the inner surface of the hosemember, e.g. in the form of a resilient vane adapted to contact theinner surface of the hose member or outer surface of the catheter,respectively. The outwardly extending protrusion of the catheter shouldin this respect be understood either as a protrusion connected to thecatheter or a protrusion formed directly on the surface of the catheter.As an example, the catheter may be connected with a plug member whichplug member is provided with vanes adapted to slide along the innersurface of the hose or at least parts thereof. Similarly, the inwardlyextending protrusion of the hose should be understood either as aprotrusion connected to the hose or a protrusion formed directly on theinner surface thereof.

Two or more radially outwardly or inwardly extending protrusions of theouter or inner surfaces of the catheter and/or the hose member, willprovide an even better sealing against flow of liquid substances betweenthe two compartments. By providing the at least two radially inwardlyextending protrusions of the inner surface of the hose member withdifferent radial sizes, a further sealing effect will be achieved.

According to a preferred embodiment, the sealing means comprises aring-shaped member arranged between the inner surface of the hose memberand the outer surface of the catheter. As an example, a regularring-shaped gasket may be placed inside the hose member. Preferably, themember is loosely arranged so that it is allowed to move back and forthinside the hose. As an example, the ring-shaped member may be providedwith a clearance against the hose member and against the catheter sothat liquid substances are substantially prevented from passing thering-shaped member and so that the ring-shaped member is still allowedto be shifted longitudinally back and forth in the catheter package.

The ring-shaped member may preferably be adapted to co-operate with aninwardly extending protrusion of the inner surface of the hose member orwith an outwardly extending protrusion of the catheter.

The distance from the distal end of the urinary catheter to the positionof the sealing means may preferably be provided between 0 and 100% ofthe total distance between the distal end of the catheter and theproximal end of the catheter, such as 0%, such as 10%, such as 20%, suchas 30%, such as 40%, such as 50%, such as 60%, such as 70%, such as 80%,such as 90%, such as 99%.

In general, the problems of introducing a catheter into urethra dependnot only on the size of the introduced part of the catheter but also onthe slipperiness of the introduced part. As previously mentioned, thecatheter or at least a part of the catheter adapted for insertion intourethra or an artificial urinary canal may often be provided with asurface slipperiness for easy and safe insertion. However, it has beenfound that the slippery surfaces are difficult to handle, not least fora user having reduced dexterity. It is therefore an important aspect ofthe present invention to allow the user to manipulate the catheter bytouching only the catheter package and only to expose a length of thecatheter, which is necessary for opening the bladder. Preferably, thesealing means is arranged so as to seal between the outer surface of thecatheter and the inner surface of the hose over a certain dismantlinglength. This will allow the user of the catheter to withdraw thecatheter at least partly from the package, e.g. by pulling the proximalend of the catheter out of the catheter package. Meanwhile, the sealingbetween the catheter and the package remains. The feature allows that acatheter type of one length can be supplied both to male and femaleusers. The user only needs to withdraw a length of the catheter from thecatheter package necessary for opening the bladder, i.e. approximately50-90 mm. for female users and approximately 180-250 mm. for male users.

The sealing means and/or the hose member may preferably be provided sothat no passage is formed between the outer surface of the catheter andthe inner surface of the hose member while the catheter is beingdismantled over a first dismantle period, thus preventing fluid frompassing between the urinary catheter and the hose member when thesealing means is positioned within said first period.

In order not to contaminate the surroundings with friction-reducingsubstances, it is an advantage to allow such a substances which maypossibly be stored in the upper receptacle to drain down into the lowerreceptacle before dismantling the catheter through the proximal end ofthe package. The sealing means and/or the hose may therefore preferablybe provided so that a clearance is defined between the outer surface ofthe urinary catheter and the inner surface of the hose member over asecond dismantling period, thus allowing a fluid to pass between theurinary catheter and the hose member when the sealing means ispositioned within said second period. As the catheter is being removedfrom the package, the catheter enters the second dismantling period. Anyliquid substance contained in the upper receptacle is thereby draineddown into the lower receptacle and it is thereby avoided that thesubstance unfortunately is released through the proximal end of thepackage.

The length of the first dismantling period may preferably constitutebetween 0 and 100% of a total length of the package, such as 0%, such as10%, such as 20%, such as 30%, such as 40%, such as 50%, such as 60%,such as 70%, such as 80%, such as 90% or such as 100%.

According to one embodiment, the substantially liquid tight seal isprovided continuously between the catheter package and the catheter overthe first dismantle period. However, the liquid tight seal may also beprovided discontinuously, e.g. stepwise.

Most catheters are provided with a surface which, when treated with afriction-reducing substance, exhibits a low friction surface character.Accordingly, it is an advantage that the package defines a liquid tightwetting pocket for treatment of the surface part with such a substance.If the catheter is hydrophilic or at least is provided with ahydrophilic surface coating on at least the proximal end thereof, thesubstance would typically be a water based solution, e.g. a salinesolution. If the catheter is not hydrophilic, the substance may e.g. bea silicone based solution.

It is a further advantage to provide the assembly with an amount of thesubstance which is sufficient for effecting a treatment of at least apart of the catheter surface. As an example, the treatment may beperformed on a first part of the catheter, which part is adapted forinsertion into the urethra. The treatment may advantageously take placein the upper receptacle.

According to a preferred embodiment of the invention, the substance iscontained in a pouch connected to the assembly. The pouch may as anexample constitute a closure for closing one of either the proximal ordistal ends of the package. Preferably, at least the proximal end of thepackage, i.e. the end located near the proximal end of the catheter, isclosed by a pouch, so that the substance can be squeezed out of thepouch and onto the proximal insertable catheter end. According toanother preferred embodiment, the substance is applied to the receptacleor at least the upper receptacle during the assembling process. The lowfriction surface character of the catheter is thereby initiated alreadyfrom the time when the catheter assembly is produced. The package istherefore preferably formed with a wall of a substantially gasimpermeable material so as to allow long time preservation of thecatheter and a liquid substance in the package.

It is an advantage to provide the package with an opening for draining aliquid substance out of the package. As an example, the opening may beused for draining out surplus liquid swelling medium remaining in thepackage after treating a hydrophilic catheter. As another example, theopening may be used for draining urine out of the package. For thispurpose, the opening is preferably provided in the distal end of thepackage. During use, the individual may simply have to withdraw a lengthof the catheter which is sufficient for causing the urine to flow fromthe bladder. The urine will flow through the catheter conduit and intothe package. The urine is allowed to drain out of the package, e.g. intothe toilet or into a collection bag or reservoir connected to thepackage, through the opening. Preferably the opening is dosed by closingmeans connected to the catheter for causing opening of the package uponremoval of the catheter from the package. As an example, the distal endof the catheter may close the opening itself.

In order to prevent that a liquid substance being drained out of thepackage flows back into the package, the opening may be provided withmeans allowing the liquid substance to flow only in a direction out ofthe package. As an example, the opening may be provided with a back-flowvalve. Such back-flow valves are known in the art.

According to a preferred embodiment, the closing means comprises a firstvalve member co-operating with a second valve member, the second valvemember being attached to the catheter.

The first valve member may have a first sealing flange adapted forsealing engagement with a corresponding second sealing flange of thesecond valve member, the second sealing valve member thereby closing theoutlet of the first valve member. The first and the second sealingflanges may then seal a passage between the hose and the surroundingsoutside the package.

The first valve member may further have a third sealing flange adaptedfor sealing engagement with a corresponding fourth sealing flange of thesecond valve member. The third and the fourth sealing flanges may thenseal a passage between the conduit of the catheter and the surroundingsoutside the package.

The back-flow valve preventing liquid substances to flow back into thepackage may be integrated into one of either the first and/or the secondvalve members, e.g. in form of a sheet or flap allowed to be displacedfrom an opening between the package and the ambient atmosphere when aliquid flows into the reservoir, whereas the sheet or flap, by means ofthe liquid, is pressed back into a position wherein it blocks thepassage between the ambient atmosphere and the package when liquid tendsto flow in the other direction.

According to a preferred embodiment of the invention, the closing meansconnected to the urinary catheter is provided with a flow channelco-operating with an outlet provided in the package. In a first positionof the closing means in relation to the outlet, liquid substances areallowed to flow from the conduit of the catheter and out of the package.In another position, a liquid substance is prevented to flow from theconduit of the catheter and out of the package. The two positionscorrespond to a catheter respectively taken out of the package or beingtaken out of the package and a catheter arranged in the package.

The flow channel of the closing means may further comprise at least oneinlet allowing a liquid substance to flow between the one of either thelower or upper storage compartments and the conduit of the catheter. Inorder to prevent urine, drained through the catheter, from running outthrough the inlet, the inlet may be provided with means adapted to allowa liquid substance only to flow in the direction from one of either thelower or upper storage compartments and into the conduit.

For disabled users there may be severe difficulties in enteringavailable toilet rooms. It is therefore an advantage to make the use ofthe catheter totally independent of the availability of toilet rooms byconnecting a distal end of the package to a reservoir for accommodationof a liquid substance. In this case, the catheter package or at leastthe hose member thereof, may even be integrated in the reservoir.

It is an advantage to provide the reservoir in a material which isdurable to at least moderate filling with a liquid without causingdestruction of the reservoir or evaporation of the liquid substancethrough the walls of the reservoir. Moreover, the walls of the reservoirshould at least substantially maintain its properties over a period ofup to 12 or more month, e.g. up to 24 month. The reservoir couldtherefore preferably be made from a thermoplastic elatomeric material,other thermoplastic materials, curable elastomeric materials, polyamideresins or elastomers or any mixture thereof, i.e. the group may comprisematerials like, PA, PP, PVC, PU, PE, latex, and/or Kraton™. Preferably,the reservoir is made from two foils of a sheet material joined alongedges, e.g. by melting or gluing the foils together. The foils may e.g.be laminated from various materials and may e.g. comprise one layer ofaluminium or a similarly metallic layer for providing a completely gasimpermeable package.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will now be described in detailswith reference to the drawing in which:

FIGS. 1 a-1 d shows parts of a catheter assembly according to apreferred embodiment of the present invention,

FIGS. 2 a-2 d shows an alternative embodiment of the assembly of FIG. 1,

FIGS. 3 a-3 e shows yet another alternative embodiment of the assemblyof FIGS. 1 and 2,

FIGS. 4 a-4 e shows an embodiment of the assembly, wherein the passagebetween the catheter and the hose is sealed over a first dismantlingsection and wherein the passage is open over a second dismantlingsection,

FIGS. 5 a-5 c shows a simple embodiment of the invention, wherein thedistal end of the package is closed by the distal end of the catheteritself,

FIGS. 6 a-6 c shows an embodiment of the assembly shown in FIG. 5,wherein the distal end of the package is closed by a detachable closure,

FIG. 7 shows an embodiment of an assembly comprising a reservoir forstorage of urine and other liquid substances,

FIG. 8 shows a perspective view of a combined valve member and aradially outwardly extending protrusion adapted to be attached to acatheter,

FIG. 9 shows a cross-sectional view of the valve member of FIG. 8,

FIG. 10 shows perspective view of a valve member to be fixed to anopening in the distal end of the package, and

FIG. 11 shows a cross-sectional side view of the valve member of FIG.10.

DETAILED DESCRIDTION OF THE INVENTION

Further scope of applicability of the present invention will becomeapparent from the detailed description given hereinafter. However, itshould be understood that the detailed description and specificexamples, while indicating preferred embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will becomeapparent to those skilled in the art from this detailed description.

Referring to FIG. 1, a catheter assembly according to the presentinvention comprises a urinary catheter 1 defining a conduit 2 fortransportation of urine and other liquid substances, a catheter package3 and sealing means 4. In this respect the catheter is defined by a hoseand by additional parts connected to the hose, e.g. the plug 25, cf.FIG. 2 a. The plug combines the sealing between the catheter and thepackage and the closing means adapted to close the distal end of thepackage—see the following description. The catheter is provided with aproximal end 5, adapted for insertion into the urethra of an individual.The catheter is provided with holes 6 arranged peripherally around theproximal end part of the catheter for draining urine from the bladderand into the conduit of the catheter. The catheter is further providedwith at least one opening 7 in the opposite distal end for drainingliquid substances out of the conduit. The package is provided with ahose 9 defining a cavity 10 for accommodation of the catheter.

The sealing means 4 is arranged between the outer surface 11 of thecatheter and the inner surface 12 of the hose member and provides asubstantially liquid tight division of the space confined between thehose member and the catheter into a lower receptacle 13 and an upperreceptacle 14.

As shown in FIG. 1, the sealing means may preferably be provided in theform of a radially outwardly extending protrusion 4, e.g. in the form ofa soft, resilient vane of the catheter or attached to the catheter andprovided in a length which enables the vane to contact the inner surfaceof the hose member.

FIG. 1 a shows a preferred embodiment of the assembly, wherein a flowchannel 15 is provided in order to allow a liquid substance to flow fromthe upper receptacle 14 and into the conduit 2, e.g. water or awater/saline solution contained in the upper receptacle for treatment ofa hydrophilic catheter or a lubricant for causing a low friction surfacecharacter of a conventional catheter.

FIG. 1 b shows one embodiment of the sealing means connected to thecatheter.

FIG. 1 c shows a situation wherein an opening 16 provided in the distalend of the package, allows liquid substances comprised in the lowerreceptacle to drain out of the package.

FIG. 1 d shows a situation wherein dosing means 17 of the catheterliquid-tightly seals the opening 16. Preferably, the closing means isprovided with a number of resilient and/or soft bulges 18 adapted tocontact the inner surface of the opening 16.

FIGS. 1 c and 1 d further shows a detachable closure 19 of the proximalend of the package. The closure may as indicated in FIGS. 1 c, 1 d,preferably be attached to the package via a strip 20, so that theassembly remains as one unit. The closure may be provided with aradially extending gripping handle 21, easing the removal of theclosure, not least for individuals with a reduced dexterity.

FIGS. 2 a, 2 b, 2 c and 2 d shows an alternative embodiment of the plug25 and an alternative embodiment of the distal package end, wherein anopen distal end of the package is closed by a closure 26. The closuremay either be detachable or glued onto the hose member 9. The plug ispreferably provided with at least one outlet opening 27 allowing urineflowing from the bladder and into the proximal end of the catheter todrain out of the catheter through the plug. The plug may further beprovided with an inlet 28 for draining a liquid substance from the upperreceptacle 14 and into the conduit 2. The closure 26 is further providedwith an opening 29 for draining liquid substances out of the lowerreceptacle, e.g. urine.

FIG. 2 c shows a situation wherein the closing means of the catheter iswithdrawn from the closure, whereby the passage 29 is opened.

FIG. 2 d shows a situation wherein the closing means of the cathetercloses the passage 29 and thereby prevents a liquid substance to drainout of the package.

The catheter and package shown in FIG. 2 is not drawn in its fulllength. The proximal ends of both parts have been omitted in order tofocus only on the differences between the embodiment of FIG. 1 and FIG.2.

FIG. 3 shows an embodiment of the invention wherein the plug 35 isprovided with features similar to the plug 25 of FIG. 2. The plugfurther comprises a groove 36 adapted to engage a ring shaped sealingmember 37. The ring shaped sealing member is provided inside the package38, either fixed to the inner surface of the hose or movably arranged sothat it is allowed to slide back and fourth in the hose.

FIG. 3 c shows a situation wherein the ring shaped member engages thegroove. Likewise the embodiment of FIG. 2, the proximal ends of both thecatheter and the package have been left out intentionally in order tofocus only on the differences between the embodiment of FIG. 2 and FIG.3.

FIG. 4 shows an embodiment of the invention where the plug 45 isprovided with resilient vanes 46 provided with a diameter so that theyover a first section 47 of the hose may contact the inner surface, whenthe plug is positioned within this section of the hose. The hose isprovided with two different radial sizes. Accordingly, since the radialsize of a second section 48 of the hose is larger than the radial sizeof the first section of the hose, the vanes 46 can not contact the innersurface of the hose, when the plug is positioned within the secondsection.

FIG. 5 shows a simple embodiment of the invention wherein the package inits distal end is provided with an opening 55. The opening may be closedby the distal end 56 of the catheter itself, whereby the distal end ofthe package is automatically opened upon removal of the catheter fromthe catheter package. As indicated, a liquid substance comprised in thepackage, e.g. a liquid swelling medium for treatment of a hydrophiliccatheter, is allowed to drain out of the package through the holes 57provided in the proximal end of the catheter. The proximal end of thecatheter and package is, for simplification of the drawing, left out ofthe FIGS. 5 a and 5 b. In FIG. 5 c, the proximal end of the package isleft out. However, the proximal end of the package may be closed e.g. bya closure of any kind.

FIG. 6 shows an embodiment of the invention, wherein the distal end ofthe package is closed by a detachable closure 60. The closure isprovided with an outlet 61 for draining liquid substances out of thepackage. In a first position of the catheter in relation to the packageand the closure, see FIG. 6 a, the outlet is closed by the distal end ofthe catheter. When the catheter is removed from the package, the outletis opened, whereby liquid substances is drained out of the package.

FIG. 7 shows an embodiment of the invention wherein the hose member isconnected to a reservoir for collection of liquid substances, e.g. forcollection of urine and/or a saline solution having been used forestablishing a low friction surface character of the catheter prior touse. The valve 70 may preferably be provided as a one-way closure, so asto ensure that liquids drained into the reservoir does not flow backthrough the hose member and/or through the catheter. The reservoir isprovided with a draining spout or valve 71 for draining the liquidsubstances out of the reservoir. As an example, the draining valve maybe opened by tearing off a top part of the valve. For this purpose thereservoir may preferably be provided with a weakening line 72. Thereservoir may preferably be formed as a bag with a substantially flatbottom part 73. Thereby it will be possible for the user to leave thereservoir on a flat surface, e.g. on the floor, while the catheter isinserted into the urethra and while urine is drained into the reservoir.Instructions relating to the opening of the draining valve maypreferably be printed on the reservoir. The handles 74, 75 give the usera better grip, e.g. when emptying the reservoir. For this purpose, itwill be specifically appropriate to use both handles in combination, sothat the reservoir is lifted in the top handles 75, while the rearhandle 74 is used to rotate the reservoir. In this respect, it should bekept in mind that the user would typically be at least partlymotorically disabled. The assembly further comprises a closure 76 foropening and closing the assembly, respectively. In the embodiment ofFIG. 7, the compartment 77 is joined telescopically to the hose 79 viathe joint 78.

FIG. 8 shows a view of a second valve member in the form of a combinedvalve member and a radially outwardly extending protrusion. The secondvalve member is adapted to be attached to a distal end of a catheter.The catheter member is on the outer surface provided with a sliding seal91 (a piston seal) and a locking ring 92. The inner surface, which isbest seen in FIG. 9, is provided with a second sealing flange 93 and afourth sealing flange 94.

FIG. 10 shows a first valve member of the package. The valve membershould be attached in an opening of the distal end of the package. Thefirst valve member is adapted to engage the corresponding second valvemember of the catheter, cf. FIGS. 8 and 9. Through the sealingengagement between the first sealing flange 101 of the first valvemember, c.f. FIG. 10, and the second sealing flange 93 of the secondvalve member, a passage between the package or hose and the surroundingsmay be sealed. Through the sealing engagement between the third sealingflange 102 of the first valve member, c.f. FIG. 10, and the fourthsealing flange 94 of the second valve member, a passage between theconduit of the catheter and the surroundings may be sealed. When thecatheter is removed from the package, or in fact already when a firstpart of the catheter is removed from the package, the second valvemember is removed from the first valve member. Accordingly, the sealingengagement between the sealing flanges is removed and liquid substancesboth from the package and from the conduit of the catheter may flow outthrough the hole. The inner sealing flange 95 of the second valvemember, c.f. FIG. 9, is provided for attaching the second valve memberto a catheter, e.g. by adhesively bonding the valve to the outer surfaceof the distal catheter end. The catheter could also be moulded in onepiece with an integrated valve part with features similar to thefeatures of the valve of FIG. 9. The stepped configuration 104, 114 ofthe first valve member, c.f. FIGS. 10 and 11 is provided to supportsealing engagement between the outer surface of the stepped part of thevalve member and an inner surface of a hose of a catheter package. Thefirst valve member may be adhesively bonded to the hose or the hose maybe moulded in one piece with an integrated valve part with the featuressimilar to the features of the valve of FIGS. 10 and 11.

The invention being thus described, it will be apparent that the samemay be varied in many ways. Such variations are not to be regarded as adeparture from the spirit and scope of the invention, and all suchmodifications as would be recognized by one skilled in the art areintended to be included within the scope of the following claims.

1. A catheter assembly allowing for non-contaminated insertion of acatheter into a body opening, said assembly comprising: a catheterdefining a conduit between a proximal end adapted for insertion into abody opening of an individual and an opposite distal end; a catheterpackage having a hose with a cavity for accommodation of the catheterand, in a proximal end of the package, an opening for dispensing theproximal end of the catheter from the catheter package; and a sealingmember configured to provide a substantially liquid tight seal betweenthe catheter package and the catheter, while the catheter is beingdispensed from the catheter package, so as to prevent urine fromdraining out of the proximal end of the catheter package during usethereof, the sealing member forming said seal between an outer surfaceof the catheter and an inner surface of the hose so as to divide thecavity into an upper receptacle located near the proximal end of thecatheter package and an oppositely located lower receptacle between thecatheter and the hose, said sealing member being movable longitudinallyrelative to the inner surface of said hose while retaining said sealduring said longitudinal movement, the sealing member configured toallow liquid in the upper receptacle to be drained into the lowerreceptacle during a stage of dispensing of said catheter from saidcatheter package.
 2. The assembly according to claim 1, wherein thesealing member comprises a radially outwardly extending protrusion ofthe outer surface of the catheter.
 3. The assembly according to claim 1,wherein the sealing member is adapted to provide a substantially liquidtight seal between the catheter package and the catheter during a firstdismantling period of the catheter's dispensing from the catheterpackage which includes use of the catheter.
 4. The assembly according toclaim 3, wherein said sealing member is configured so that a liquid flowchannel is defined between the catheter package and the catheter duringa second dismantling period of the catheter's dispensing from thecatheter package.
 5. The assembly according to claim 1, wherein the hoseis provided with an internal surface having two radial sizes so that theinternal clearance of the hose increases from a first internal clearancein one end to a second internal clearance in the opposite end, the firstinternal clearance providing a substantially liquid tight seal betweenthe internal surface of the hose and the catheter and the secondinternal clearance providing a liquid flow channel between the internalsurface of the hose and the catheter.
 6. The assembly according to claim1, wherein the hose is provided with a substantially circularcross-sectional shape.
 7. The assembly according to claim 1, wherein thecatheter package is provided with an opening for draining a liquidsubstance out of the catheter package, said opening being closed by aclosing structure connected to said catheter for causing opening of thecatheter package upon removal of the catheter from the catheter package.8. The assembly according to claim 7, wherein the opening is provided inthe distal end of the catheter package.
 9. The assembly according toclaim 7, wherein the opening is closed by a distal end of the catheteritself prior to dispensing of said catheter from said catheter package.10. The assembly according to claim 7, wherein the closing structureincludes a first valve member co-operating with a second valve member ofthe catheter.
 11. The assembly according to claim 10, wherein the firstvalve member includes a first sealing flange adapted for sealingengagement with a corresponding second sealing flange of the secondvalve member, the second sealing valve member thereby closing the outletof the first valve member.
 12. The assembly according to claim 11,wherein the sealing engagement between the first and the second sealingflanges seals a passage between the hose and the surroundings outsidethe catheter package.
 13. The assembly according to claim 10, whereinthe first valve member further includes a third sealing flange adaptedfor sealing engagement with a corresponding fourth sealing flange of thesecond valve member.
 14. The assembly according to claim 13 wherein theengagement between the third and the fourth sealing flanges seals apassage between the conduit of the catheter and the surroundings outsidethe catheter package.
 15. The assembly according to claim 10, whereinthe closing structure includes a flow channel with at least one inletallowing a liquid substance to flow between one of either said lowerreceptacle or said upper receptacle of said cavity and the conduit ofthe catheter.
 16. The assembly according to claim 15, wherein the inletof the closing structure is adapted to allow a liquid substance to flowsubstantially in one direction and to prevent a liquid substance to flowin the opposite direction.
 17. The assembly according to claim 16,wherein said direction is the direction from one of either the lower orupper receptacles and into the conduit.
 18. The assembly according toclaim 1, wherein the distal end of the catheter package is connected toa reservoir for accommodation of a liquid substance.
 19. A catheterassembly allowing for non-contaminated insertion of a catheter into aurinary canal, said assembly comprising: a urinary catheter defining aconduit between a proximal end adapted for insertion into a urinarycanal and an opposite distal end; a catheter package having a cavity foraccommodation of the urinary catheter and, in a proximal end of thecatheter package, an opening for dispensing the proximal end of theurinary catheter from the catheter package; and a sealing memberarranged between an outer surface of the urinary catheter and an innersurface of the catheter package so as to divide said cavity into anupper receptacle located near the proximal end of the catheter packageand an oppositely located lower receptacle between the urinary catheterand the catheter package, said sealing member configured to provide asubstantially liquid tight seal between the catheter package and theurinary catheter during a first dismantling period of the urinarycatheter's dispensing from the catheter package which includes use ofthe urinary catheter so as to prevent urine from draining out of theproximal end of the catheter package, said sealing member in said firstdismantling period being movable longitudinally relative to an innersurface of said catheter package while retaining said seal during saidlongitudinal movement, and said sealing member being further configured,during a second dismantling period of the urinary catheter's dispensingfrom the catheter package, to define a liquid flow channel between thecatheter package and the urinary catheter to allow liquid in the upperreceptacle to be drained into the lower receptacle and out a distal endof said catheter package.
 20. The assembly according to claim 19,wherein the catheter package cavity is provided with an internal surfacehaving two radial sizes so that the internal clearance of the catheterpackage cavity increases from a first internal clearance in one end to asecond internal clearance in the opposite end, the first internalclearance providing the substantially liquid tight seal between thecatheter package and the urinary catheter and the second internalclearance providing said liquid flow channel between the catheterpackage and the urinary catheter to allow liquid in the upper receptacleto be drained into the lower receptacle.